Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT06268652
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Organoid-guided personalized treatment — OTHER
    After the organoid culture is successful, the personalized drug library customized by our team will be used for screening. Sensitive drugs are selected based on the results of drug screening, and the most appropriate personalized treatment plan is selected based on NCCN guideline recommendations, drug safety, and conventional drugs used in the treatment of breast cancer. The personalized drug library customized by our team contains 55 drugs approved by the FDA. For specific usage, dosage and time intervals, please refer to the instructions of the corresponding drug.
  • Gemcitabine — DRUG
    1000mg/m2，IV, days 1, 8, q3w
  • Capecitabine — DRUG
    1000mg/m² , PO, bid, days1-14, q3w
  • Vinorelbine — DRUG
    25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w
  • Eribulin — DRUG
    1.4mg/m², IV, days 1 and 8, q3w

Study Details

This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.

Key Dates

Start date
Jan 15, 2024
Status verified
Feb 2024
Primary completion
Feb 15, 2026
Completion
Jan 15, 2028

Study Design

Enrollment
302 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Organoid-guided personalized treatment
    Subjects randomly assigned to OGPT need to provide sufficient tissue for organoid culture. After successful organoid culture, drug screening will be performed, and they will be treated with drugs predicted to be sensitive by PDO drug susceptibility screening.
  • Active Comparator: Treatment of physician's choice
    Subjects in the TPC arm will receive treatment with one of the following regimens selected by the physician following NCCN guidelines: capecitabine, gemcitabine, vinorelbine, and eribulin. If it is HER2-positive, anti-HER2 therapy can be combined with it, except for ADC drugs.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Within approximately 48 months ]

Central Contacts

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